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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00511173
Other study ID # 06-14171
Secondary ID
Status Completed
Phase Phase 4
First received August 1, 2007
Last updated December 7, 2012
Start date August 2006
Est. completion date November 2008

Study information

Verified date December 2012
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.


Description:

Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria:

- Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

Exclusion Criteria:

- Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Genetic:
Warfarin Dose based on pharmacogenetics
Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Creighton University

Outcome

Type Measure Description Time frame Safety issue
Primary In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk). six months No
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